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A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans (PEAK2)

Arkansas Children's Hospital Research Institute logo

Arkansas Children's Hospital Research Institute

Status

Completed

Conditions

Asthma

Treatments

Device: Mobile Phone
Other: Paper Asthma Action Plan

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.

Full description

The investigators propose to conduct a randomized trial to examine the effectiveness of a mobile-based Asthma Action Plan that will meet the national guidelines recommendation for individualized Asthma Action Plan treatment plans. The mobile app will provide immediate instructions and feedback once data is entered by the participants. This is an randomized trial which will be compared with an paper asthma action plan. Participants will be randomized through a statistical table. The mobile app will be password and Health Information Portability and Protection Act protected.

Enrollment

34 patients

Sex

All

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age ≥ 12 and ≤ 17 years.

  • Access to Apple or Android based smart phone

  • Mild to severe persistent asthma or poorly controlled asthma (see definitions below).

    o A different assessment of eligibility will be performed depending on whether or not the parent reports use of a preventive asthma medication at baseline. This is consistent with 2007 National Asthma Education Prevention Program recommendations that make a strong distinction between classifying asthma severity (for children not using preventive medications) and assessing control (for children using preventive medications). If a child has used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will assess severity.)

  • Children not using a preventive medication at baseline: Assess for mild persistent to severe persistent asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine severity:

    • An average of >2 days per week with asthma symptoms
    • >2 days per week with rescue medication use
    • ≥2 nights per month awakened with nighttime symptoms
    • Minor limitation of activity
    • ≥2 episodes of asthma during the past year that have required systemic corticosteroids
  • Children using a preventive medication at baseline: Assess for poorly controlled asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine control:

    • An average of >2 days per week with asthma symptoms
    • >2 days per week with rescue medication use
    • ≥2 nights per month awakened with nighttime symptoms
    • Some limitation of activity
    • ≥2 episodes of asthma during the past year that have required systemic corticosteroids.

Exclusion criteria

  • Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
  • Significant co-morbid conditions (such as moderate to severe developmental delay, i.e. special education classroom or diagnosis) that could preclude participation in an education-based intervention.
  • Inability to speak or understand English (child or parent).
  • Children in foster care or other situations in which consent cannot be obtained from a guardian.
  • Prior enrollment in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Paper Asthma Action Plan
Experimental group
Description:
Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Treatment:
Other: Paper Asthma Action Plan
Mobile Phone
Experimental group
Description:
Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Treatment:
Device: Mobile Phone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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